CLO TEST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-20 for CLO TEST * manufactured by Delta West Pty Ltd..

Event Text Entries

[61289] This test has recently been clia waived. None of the users are doing the quality control as the mfr recommends. The mfr states to use proteus or h. Pylori as a positive control. The distributor states to use jack bean urease as a positive control.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1011327
• MDR Report Key: 92063
• Date Received: 1997-05-20
• Date of Report: 1997-05-13
• Date Added to Maude: 1997-05-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CLO TEST
• Generic Name: TESTING KIT FOR H. PYLORI
• Product Code: JSI
• Date Received: 1997-05-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 90939
• Manufacturer: DELTA WEST PTY LTD.
• Manufacturer Address: 15 BRODIE HALL DR. BENTLEY AS

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-05-20